Pharmacist Interventions in Rural Elderly Warfarin Patients

The Influence of Pharmacist Interventions on the Effectiveness of Warfarin Treatment in Elderly Patients From Rural Areas

The primary study goal is to explore the influence of pharmacist interventions on the effectiveness of warfarin treatment in a specific subpopulation.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Thrombosis; Atrial Fibrillation; Cardiac Failure
• Intervention / Treatment: Other: anticoagulation care

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥65 years
• Living site of participant outside the city eg. rural site
• Expected duration of warfarin therapy at least 6 months from the inclusion in the study and 3 months before

Exclusion Criteria:

• Hospitalization
• Vegetarianism
• Patients not able to provide an informed consent
• The use of drug that has an X level of clinical significance of interaction with warfarin according to Lexicomp interact base

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Specific pharmacist-led anticoagulation care	Other: anticoagulation care; Patients in the intervention group will: 1) have a repeated pharmacist-led education on all aspects of warfarin treatment; 2) receive enhanced medication instructions and a care and follow up plan; 3) receive a pill box 4) be refered to the GP with proposal for dose change when outside the therapeutic range or therapy modification to avoid drug interactions with warfarin
NO_INTERVENTION: Control; The control group will receive usual care; no interventions will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in therapeutic range (TTR)	Time in therapeutic range by Rosendaal method (percentage of time in therapeutic range)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse drug reactions	To measure the difference in number and types of adverse drug reactions between the intervention and the control group	6 months
Time to adverse drug reaction	To measure the difference in time to adverse drug reactions between the intervention and the control group	6 months
International randomised ratio	To measure the difference in patterns of the International randomised ratio between the intervention and the control group	6 months
Adherence	To measure the difference in adherence between the intervention and the control group	6 months
Quality of life	To measure the difference of the quality of life in the intervention and the control group at the beginning and the end of the study (validated Croatian version of DUKE - Duke anticoagulation satisfaction scale questionaire)	6 months
Incidence and influence of clinically significant drug interactions	To measure the incidence of clinically significant drug interactions (defined by the Lexicomp-interact base as degree C and D of clinical significance) and influence of drug interactions on the effectiveness and safety of treatment between the intervention and the control group	6 months
Dietary intake of vitamin K	Changes of dietary intake of vitamin K	6 months
Acceptance of pharmacist's intervention by the general practitioners	To measure the rate of acceptance of pharmacist's interventions by the general practitioners	6 months

Collaborators and Investigators

• Sponsor: Slaven Falamić
• Investigators: Principal Investigator: Slaven Falamić, MPharm, Pharmacy Branka Marušić

Publications and helpful links

General Publications

• Falamic S, Lucijanic M, Ortner-Hadziabdic M, Marusic S, Bacic-Vrca V. Pharmacists' interventions improve health-related quality of life of rural older person on warfarin: a randomized controlled trial. Sci Rep. 2021 Nov 9;11(1):21897. doi: 10.1038/s41598-021-01394-0.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2015
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (ACTUAL): July 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: pharmacist interventions, warfarin, elderly rural patients
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation; Hemorrhage; Thrombosis
• Other Study ID Numbers: SFalamic

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No